Prevalence of Morphologic and Metabolic Anormalities in HIV Infected and Uninfected Young Men

University of North Carolina, Chapel Hill13 sites in 2 countries250 target enrollmentMarch 2006

ConditionsHIV Infections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HIV Infections
Sponsor: University of North Carolina, Chapel Hill
Enrollment: 250
Locations: 13
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To assess whether there exist significant differences in glucose metabolism, lipids, lactate, body composition, and bone density between HIV-infected and uninfected young men.

Detailed Description

The study involves a one-time collection of health and medical history data, blood and urine specimens, and physical assessments. This study will elucidate the need for a further in-depth study to understand the pathophysiological effects of protease inhibitor (PI)-based and non-nucleoside analogue reverse transcriptase inhibitor (NNRTI)-based therapies in young men.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

August 2007

Last Updated

9 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

University of North Carolina, Chapel Hill

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Males age 12 years and 0 days through 24 years and 364 days.
•Tanner stage 4 or
•Accessible medical history and medications history.
•Willingness to fast and complete all clinical evaluations and specimen collection.
•Willingness and ability to give informed consent or assent with parental/legal guardian permission, where required.
•Group 1: HIV-Negative Control Subject Specific Inclusion Criteria
•All subjects for Group 1 will be tested for HIV-1 to confirm negativity unless they have a documented negative antibody test within the last three months of study entry.
•Willingness and ability to give informed consent for HIV testing. Groups 2, 3, and 4: HIV-Positive Subject Specific Inclusion Criteria
•HIV-1 infection as documented by a positive result on any of the following licensed tests at any time: any antibody test confirmed by Western blot, HIV culture, plasma HIV-1 RNA PCR \>1,000 copies/ml or HIV-1 DNA PCR.
•Horizontal HIV infection transmission (non-perinatal, non-transfusion acquired infection).

Exclusion Criteria

•Transgender male to female (MTF) or female to male (FTM) youth
•Refusal to fast for the 8 hours before collection of laboratory specimen requiring fasting.
•Unable to obtain medical/medications history.
•History of anorexia or bulimia.
•Type I Diabetes Mellitus.
•Type II Diabetes Mellitus and cannot omit diabetes medication for the 48-hour period prior to laboratory specimen collection for oral glucose tolerance test (OGTT).
•Current use or use within the past 6 months of oxandrolone, nandrolone, oxymetholone, stanozolol, or any other synthetic anabolic/androgenic agents.
•Current use or use within the past 6 months of pharmacologic doses of growth hormone. Physiologic growth hormone replacement therapy is permitted, as long as dosages meet the following specifications:
•Adolescents in puberty - less than or equal to an equivalent of 0.1 mg/kg/day
•Adolescents past puberty - less than or equal to an equivalent of 0.025 mg/kg/day